Bi-specific CAR-T cell therapy for B cell malignancies
CD19/22 Bi-specific CAR-T Cells Targeting B Cell Malignancies
PHASE1; PHASE2 · Shenzhen Geno-Immune Medical Institute · NCT05432882
This study is testing a new type of CAR-T cell therapy that targets two specific proteins to see if it can help people with tough-to-treat B cell cancers feel better and live longer.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Months to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute (other) |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05432882 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, feasibility, and efficacy of a novel anti-CD19/22 bi-specific CAR-T cell therapy in patients with CD19 and/or CD22 positive B cell malignancies. It aims to address the limitations of existing CAR-T therapies by using genetically modified T cells that can target both CD19 and CD22 antigens, potentially improving treatment outcomes for patients with refractory and recurrent cancers. The study will assess the persistence and function of these bi-specific CAR-T cells in the patient population, with a focus on long-term efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates include patients over 6 months old with malignant B cell tumors expressing CD19 or CD22 and a KPS score above 80.
Not a fit: Patients with active infections, other serious diseases, or those who have previously failed CD19 and CD22 CAR-T treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat B cell malignancies.
How similar studies have performed: While CAR-T therapies have shown promise, this bi-specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age older than 6 months. 2. malignant B cell surface expression of CD19 or CD22 molecules. 3. the KPS score over 80 points, and survival time is more than 1 month. 4. greater than Hgb 80 g/L.5. no contraindications to blood cell collection. Exclusion Criteria: 1. accompanied with other active diseases and difficult to assess patient response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with HIV.4. active HBV or HCV infection. 5\. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CD19 and CD22 CAR-T treatment.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Lung-Ji Chang, PhD
- Email: c@szgimi.org
- Phone: 86-0755-86725195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: B Cell Malignancies, CAR-T, B cell Malignancies, CD19, CD22